TOPLINE:

Sudden death (SD) was a leading cause of cardiovascular death in patients across the cardio-kidney-metabolic (CKM) spectrum, including those with chronic kidney disease (CKD), type 2 diabetes (T2D), or heart failure (HF). Patients treated with finerenone had a reduced risk for SD.

METHODOLOGY:

• In a prespecified analysis (FINE-HEART), researchers pooled data from three international phase 3 randomized controlled trials to assess whether finerenone treatment affected the risk for SD across the CKM spectrum.
• They included 18,991 adults from two trials involving patients with CKD and T2D and one trial involving patients with HF with mildly reduced or preserved ejection fraction. The mean age ranged from 67.0 to 69.3 years across trials, and 34.2%-35.1% of the adults were women.
• Patients were randomly assigned to receive finerenone or placebo once daily, with initial doses of 10-20 mg titrated to 20-40 mg according to the estimated glomerular filtration rate and trial protocols.
• Researchers used an adapted American Heart Association 2023 framework to classify patients into CKM stages 2-4.
• The primary endpoint was the incidence of SD over a median follow-up of 2.9 years.

TAKEAWAY:

• SD occurred in 418 patients (2.2%), accounting for 47% of cardiovascular deaths.
• Patients with stage 4 CKM syndrome had a 2.7-fold higher risk for SD than those with stage 2 or 3 CKM syndrome (P < .001).
• Finerenone was associated with a 19% lower risk for SD than placebo (P = .034), equating to one prevented SD per 216 treated patients over the study period.
• Independent predictors of SD included older age, a history of HF, atrial fibrillation, prior myocardial infarction, a higher urine albumin-to-creatinine ratio, lower systolic blood pressure, and reduced kidney function (P < .05 for all).

IN PRACTICE:

“These findings underscore SD as a key contributor to the mortality burden in CKM syndrome and broaden the evidence supporting finerenone use beyond traditional CV [cardiovascular] and kidney outcomes, suggesting a possible role in mitigating arrhythmic risk in this population,” the researchers wrote.

SOURCE:

The study was led by Alberto Foà, MD, PhD, of IRCCS Azienda Ospedaliero-Universitaria di Bologna in Bologna, Italy. It was published online on June 3 in JACC.

LIMITATIONS:

The cause of death may have been misclassified because some SDs were not confirmed by autopsy. The three trials had different designs and eligibility. The study excluded the earliest and the most advanced CKM stages, so the results may not apply to all real-world patients.

DISCLOSURES:

The trials included in the pooled analysis received funding from Bayer AG. Several authors reported receiving grants, consulting or lecture fees, research or trial payments, employment or equity interests, or patent or license arrangements from multiple pharmaceutical, biotech, and medical‑device companies, including Bayer, and some reported research funding from nonprofit sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.